Selective Pudendal Nerve Stimulation via Physiological Feedback

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Solution Overview

Problem

Current methods for positioning electrodes for pudendal nerve stimulation lack precision, leading to non-selective modulation of the external urethral sphincter (EUS) or external anal sphincter (EAS), resulting in unwanted physiological responses due to the complexity and variation of pudendal nerve branching among individuals.

Innovation Solution

A method involving the detection of specific physiological responses to adjust electrode positioning and stimulatory signal parameters iteratively to achieve selective modulation of either the EUS or EAS, ensuring accurate targeting and minimizing unwanted stimulation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If electrode positioning is performed by visual inspection of pelvic anatomy and neural branch points, then the positioning process is simple and quick, but the stimulation becomes non-selective and elicits multiple unwanted physiological responses

Engineering Contradiction:
Improveelectrode positioning processVSAvoidstimulation targeting precision
Core Design Contradiction:
Ease of operationVSManufacturing precision

Solution Approach 1:

The patent employs a feedback mechanism where physiological responses are monitored in real-time during stimulation. The system detects whether the desired selective modulation is achieved and provides feedback to adjust electrode positioning or stimulation parameters accordingly, ensuring precise targeting while maintaining operational simplicity

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system uses the subject's own physiological responses as a guide for achieving proper electrode positioning. By monitoring whether the stimulation produces the desired selective effect (e.g., modulating EUS without affecting EAS), the system allows the physiological feedback itself to indicate correct positioning, eliminating the need for complex anatomical navigation

Inventive Principle:
Principle #25Self-service

2Loss of time

If electrode positioning relies on visual inspection alone without physiological feedback, then the procedure is faster and simpler, but treatment efficacy is reduced due to non-selective modulation

Engineering Contradiction:
Improveelectrode positioning timeVSAvoidtreatment efficacy
Core Design Contradiction:
Loss of timeVSReliability

Solution Approach 1:

The patent performs preliminary physiological testing during the positioning phase. Before finalizing electrode placement, the system applies test stimulation and monitors physiological responses to confirm selective modulation is achieved, ensuring treatment efficacy is established before full treatment begins

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent replaces reliance on mechanical/anatomical navigation (visual inspection of pelvic structures) with a physiological detection system. Instead of using anatomical landmarks alone, the system uses real-time monitoring of physiological responses to guide and confirm proper electrode positioning, substituting mechanical precision with physiological feedback

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

This approach enables precise selective modulation of the EUS or EAS, improving treatment efficacy for bladder dysfunction and faecal incontinence by enhancing voiding efficiency and patient comfort, while reducing nonspecific stimulation and discomfort.

Implementation Method 1

positioning an electrode for stimulating a first target pudendal nerve in a subject, wherein the electrode is configured to apply a stimulatory electrical signal to stimulate a target pudendal nerve

Methodology Applied
Scientific EffectElectrical stimulation: Electrical Impedance Tomography

Implementation Method 2

detecting the magnitude of a first physiological response and the magnitude of a second physiological response in response to the first stimulatory electrical signal applied by an electrode

Methodology Applied
Scientific EffectPhysiological response detection:

Data Source

PatentUS20230021801A1Method for Selective Modulation
Publication Date: 2023.01.26 AMBER THERAPEUTICS HOLDINGS LTD
  • US20230021801A1 patent drawing
  • US20230021801A1 patent drawing
  • US20230021801A1 patent drawing

AI summary

Provided herein is a solution to the problem of stimulation of a target pudendal nerve such that the stimulation applied by the electrode at that position selectively modulates the external urtheral sphincter (EUS), or selectively modulates the external anal sphincter (EAS).